The pharmaceutical company Merck on Tuesday sued the government over a federal law that empowers Medicare for the first time to negotiate prices directly with drugmakers.
Merck’s lawsuit, filed in federal court in Washington, is the drug industry’s most significant move so far to fight back against a substantial change to health policy, which will go into effect starting in 2026. Democrats pushed through the Medicare-negotiation program last summer as a provision of the Inflation Reduction Act, framing it as a way of lowering drug prices.
Only some drugs will be subject to negotiation with Medicare and only after they have been on the market without competition for years. But Merck, which generated $14.5 billion in profit last year, claimed in a statement on Tuesday that the law would stifle its ability and that of its peers to make risky investments in new cures.
Other drug companies have suggested that they will choose to cut certain drug development programs because of the projected dent to their revenue. Several have already said they were reassessing their research plans.
Merck said it was seeking a court order or another legal remedy that could exempt Merck from having to participate in the negotiation program.
In the complaint filed Tuesday, the company’s lawyers at the law firm Jones Day claim that the Medicare-negotiation program is unconstitutional. They claim that the program would coerce Merck to provide its products at government-set prices, violating a clause of the Fifth Amendment that prohibits the government from taking private property for public use without just compensation. They also claim that the program would violate Merck’s free-speech rights by coercing the company to sign an agreement it did not agree with upon the conclusion of the negotiation.
But several experts who study the industry said the constitutionality arguments were weak and would face an uphill battle in court. “What Merck argues is ‘coercion’ is actually the establishment of a freer, more rational marketplace” that will address a crucial root cause of high drug prices, said Dr. Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School.
Experts noted that the negotiation process gives drug makers leeway to reject Medicare’s final offer and walk away without a deal if they are not happy, subject to a tax.
In September, the government plans to announce the first 10 drugs that will be subject to negotiation in 2026. A widely used Merck drug for diabetes known as Januvia is likely to be on that list.
The program could also affect Merck’s long-term plans for its golden goose, the blockbuster cancer drug Keytruda. It could be among the first products targeted when negotiations begin in 2028 on drugs administered in a health care setting.
The current version of Keytruda, administered as an infusion, will face its first competition that same year, so its sales are expected to erode regardless of whether it is targeted by the program. But Merck had been expecting to bring in significant revenue from a new formulation of Keytruda it is developing that can be more easily given under the skin. That could be subject to negotiation, too, under the government’s plans for the program.
The White House did not have any immediate comment on Merck’s lawsuit.
Sheryl Gay Stolberg contributed reporting.
Column: Right-wing judges are on a mission to stop the FDA from warning consumers about snake oil
To anyone who has paid even a modicum of serious attention to COVID-19 and its treatment, ivermectin is the zombiest of zombie drugs.
Used to treat parasitic diseases in animals and humans, the drug became a darling of anti-vaccination activists and conspiracy-mongers, who pushed it as a treatment for the pandemic disease and claimed it was being suppressed by Big Pharma, among other sinister forces.
Contrary to its continued promotion by quacks such as Florida Surgeon General Joseph Ladapo, the drug has been conclusively shown to be utterly useless against COVID.
You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.
— Food and Drug Administration counsels against a useless COVID treatment
One would have hoped that hard scientific evidence and a stern advisory by the Food and Drug Administration against its use would have been enough to kill the ivermectin craze, but it lives on. Last year, three doctors sued the FDA, claiming that its public warning harmed their practices and cost them their jobs at hospitals and medical schools.
A few months later, a federal judge in Galveston threw out their case, ruling in effect that they didn’t come close to having a leg to stand on. That should have been an end to it. But earlier this month, the case was revived by the U.S. 5th Circuit Court of Appeals, which takes cases from Texas, Louisiana and Mississippi and is, by many measures, the hackiest of hack-ridden federal courts.
The three judges hearing this appeal — two appointed by George W. Bush and one (the opinion’s author) by Donald Trump — found that the FDA had exceeded its authority in advising against the use of ivermectin against COVID. “The FDA can inform,” the court said, “but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” (Emphasis in the original.)
That’s absurd, says Dorit Rubinstein Reiss, an expert on vaccine policy at University of California College of the Law, San Francisco, and the author of a withering analysis of the 5th Circuit opinion.
The FDA’s job, Reiss told me, is to “balance the need for treatment with safety concerns. If the FDA can’t translate what it’s finding into plain language — ‘do this, don’t do that’ — then it can’t do its job. That undermines the whole regulatory scheme.”
More on that in a moment. First, some context.
Undermining the FDA’s authority has been a right-wing project for years. That’s because the agency’s duty is to stand in the way of businesses desiring to push unsafe and ineffective nostrums at unwary consumers, and also in the way of a perverse idea that personal freedom includes the freedom to be gulled by charlatans.
This campaign got pumped up during the Trump administration. Trump in 2018 signed a federal “right-to-try” law that masqueraded as a compassionate path giving sufferers of intractable, incurable diseases access to experimental treatments. In fact, as I wrote, it was a cynical ploy backed by the Koch brothers’ network aimed at emasculating the FDA in a way that would undermine public health.
Trump subsequently browbeat his maladroit FDA chairman, Stephen Hahn, into issuing an emergency authorization for the use of convalescent plasma to treat COVID-19 patients. Like ivermectin, that was another utterly ineffective treatment.
In announcing his decision while Trump stood glaring at him, Hahn grossly misrepresented the results of a medical trial conducted by the Mayo Clinic, which failed to demonstrate any effectiveness for the treatment. In the run-up to the announcement, Trump issued a tweet accusing “the deep state … at the FDA” of deliberately delaying effective COVID treatments until after the upcoming Nov. 3, 2020, election, which Trump lost. Hahn didn’t respond to that frontal attack on his agency’s integrity.
The FDA is under more solid management now, but the malign influence of judges Trump installed in the federal judiciary lives on. That brings us to the 5th Circuit, on which 12 of the 16 currently active judges were appointed by Republican presidents — six by Trump.
The court has received appeals of some of the loopiest district court rulings of recent memory, largely because conservative litigants in Texas have the ability to hand-pick judges who see things their way.
Among the recent rulings those judges have issued that swear at precedent and common sense are those outlawing the use of the medication mifepristone for abortion (another case aimed at undermining FDA authority) and barring agencies of the federal government from communicating with social media companies, which was brought by right-wing litigants hoping to hobble the government’s battle against medical misinformation.
The 5th Circuit judges have frequently matched the district court rulings they’re reviewing with loopy opinions of their own.
Trump appointee James Ho issued a partial concurrence in the mifepristone case in which he asserted that an “unborn child” was “killed by mifepristone,” and justified outlawing use of the drug by stating that “unborn babies are a source of profound joy for those who view them. Expectant parents eagerly share ultrasound photos with loved ones. Friends and family cheer at the sight of an unborn child. Doctors delight in working with their unborn patients — and experience an aesthetic injury when they are aborted.”
(The court narrowed the FDA’s authority to approve the drug, but its ruling is under review by the Supreme Court.)
In a 2019 case, a three-judge panel voted 2-1 to find that a key provision of the Affordable Care Act, and possibly the entire law, was unconstitutional. In her concurrence, Jennifer Walker Elrod, a George W. Bush appointee in the majority, approvingly repeated a right-wing congressman’s claim that the act was “a fraud on the American people.”
The 5th Circuit judges combine their clownish approach to the law with a clownish confusion over the federal rules of procedure they are bound to apply. As recently as Tuesday, the appeals court had to withdraw an order it had issued the day before, granting red state plaintiffs a rehearing in the case involving government contacts with social media companies.
The court had originally allowed four government agencies to continue interacting with the companies; the red states wanted the judges to withdraw their permission. But the court’s granting of a rehearing so flagrantly violated procedural rules governing cases, like this one, that are already under consideration by the Supreme Court, that it had to immediately backtrack. (The circuit’s clerk of the court obligingly accepted the blame, attributing Monday’s grant to a “clerical error.”
The judges who made this blunder — Elrod, Edith Brown Clement and Don R. Willett — are the same ones who ruled in the ivermectin case. Let’s take another gander at that ruling.
Reiss terms the ruling “problematic on legal and policy grounds” by “undercutting the FDA’s ability to offer expertise-based guidance about products they regulate.”
The judges were particularly exercised by an FDA Twitter campaign that aimed to dissuade consumers from taking the veterinary preparation of ivermectin commonly administered to horses.
“You are not a horse,” the agency tweeted. “Stop it with the #ivermectin. It’s not authorized for treating #COVID.” The agency also issued a general warning headlined “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” explaining that the drug has not been shown to be effective for the purpose and is dangerous in high doses.
The three plaintiff doctors — one from Virginia, one from Texas, and one practicing in Washington and Arizona — had lost their hospital privileges or other professional positions for promoting the drug. The latter plaintiff is under investigation by medical regulators in the two states where he’s licensed. All three blamed the FDA.
The 5th Circuit judges agreed that even though the agency pointed out that it has no power to order patients to do or not do anything and no authority over physicians — who have the legal right to prescribe medications approved by the FDA for “off-label” uses — it had exceeded its authority by using “imperative” language (i.e., “Stop it”) instead of merely declaring that the drug wasn’t approved for COVID.
Yet as Reiss points out, the FDA frequently couches its advisories in such straightforward terms, and has done so virtually since its creation in its present form in 1930. The agency’s warning against unproven stem cell treatments — a dark and dangerous hive of medical charlatans — advises patients, “Don’t believe the hype” and adds that it’s “increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics.”
Carrying the 5th Circuit’s ruling to its logical extreme, the agency’s stem cell warning would exacerbate the vulnerability of disease sufferers to quacks hawking expensive and ineffective treatments.
Despite the judges’ contention that it has no authority to offer recommendations to the public, Reiss notes that such authority is actually embedded in federal law, which gives the FDA the right to undertake “collecting, reporting, and illustrating the results of [its] investigations.”
“That certainly seems to include conclusions based on the data collected,” Reiss wrote: “Reporting on the result of an investigation that showed ivermectin is not effective for COVID-19 would naturally include a comment that it should not be used.”
In any event, there’s no case to be made that the FDA warnings caused the doctors’ professional troubles. Several professional organizations have warned of the ineffectiveness of ivermectin for COVID, including the American Medical Assn. No medical board needed the FDA to tell it that doctors prescribing this modern snake oil deserved scrutiny.
It’s possible that the appellate judges themselves had an inkling that they were on thin ice in their ruling. They didn’t rule conclusively that the FDA was wrong, but rather sent the case back to the trial court judge for further pondering on technical grounds, such as whether the FDA’s advisories amount to “final agency actions” subject to court review or whether the doctors even had standing to bring the lawsuit in the first case.
“They seem to be trying to hedge,” Reiss says. On the other hand, they didn’t dismiss the case outright, as they should have. The judges cast a shadow over the FDA, at a time when its crucial, lifesaving campaign against medical misinformation doesn’t need any more head winds.
An Ancient Whale Named for King Tut, but Moby-Dinky in Size
In 1842, a vast, nearly intact skeleton was unearthed on a plantation in Alabama; it was soon identified as a member of Basilosaurus, a recently named genus of prehistoric sea serpent. But when some of its enormous bones were shipped to England, Richard Owen, an anatomist, noted that its molars had two roots, not one, a dental morphology unknown in any reptile. He determined that the fossil was actually a marine mammal: a primitive whale. Herman Melville name-drops the behemoth — Mr. Owen called it Zeuglodon — in Chapter 104 of “Moby-Dick,” and Mr. Owen, in a paper that he read to the London Geological Society, pronounced it “one of the most extraordinary creatures which the mutations of the globe have blotted out of existence.”
In August, a team of paleontologists announced the discovery of another extraordinary creature that was blotted out of existence. Eleven years ago, while working in the Fayum Depression of the Western Desert in Egypt, the team excavated the fossil of what they initially thought was a small amphibian. But closer inspection revealed that the bones belonged to a previously unknown species of miniature whale that existed during the late middle Eocene, in a period called the Bartonian Age, which lasted from about 48 million to 38 million years ago. The species, described in a paper in the journal Communications Biology, inhabited the Tethys Sea, the tropical precursor of the Mediterranean, which covered about a third of what is now northern Africa.
Ishmael, the protagonist of “Moby-Dick,” asserts somewhat disingenuously that a whale is a “spouting fish with a horizontal tail.” The newly documented specimen looked less like a fish than a bottlenose dolphin, with a less-bulbous forehead and a more elongated body and tail. Based on a skull, jaw, teeth and vertebrae fragments embedded in compacted limestone, researchers inferred that the wee whale, which dates back some 41 million years, was about eight feet long and weighed roughly 400 pounds, making it the tiniest known member of the basilosaurid family.
All whales are descended from terrestrial animals that ventured into the sea. Some early whales evolved into forms that ventured back onto land; basilosaurids are thought to be the first widespread group to have stuck with the sea life. They were also the last to have hind limbs that were still recognizable as legs, which were probably used less for locomotion than as reproductive guides to help orient the whales during sex.
Melville dismissed whale taxonomy as “mere sounds, full of Leviathanism, but signifying nothing.” He likely would have had little use for Tutcetus rayanensis, the official name of the small-scale whale ancestor. Tutcetus combines Tut — recalling the pharaoh Tutankhamen — and cetus, Greek for whale. The designation also follows the centenary of the discovery of King Tut’s tomb, and coincides with the impending opening of the Grand Egyptian Museum in Giza, Egypt. The “rayan” part of the name derives from the Wadi El-Rayan Protected Area, which sits about 25 miles northeast of a site so rich in fossil whales that it has been called Wadi Al-Hitan, or Valley of the Whales.
Like Tut, who died in the Valley of the Kings at age 18, the whale is believed to have been a juvenile nearing adulthood. The research team used CT scanning to analyze Tutcetus’s teeth and bones, reconstructing its growth patterns. The bones of the skull had fused, as had parts of the first vertebrae, and while some of the teeth had emerged, some were still in transition. The rapid dental development and small bone size of Tutcetus suggest a short, fast life compared with larger and later basilosaurids, said Hesham Sallam, a paleontologist at the American University of Cairo and leader of the project.
The whale may have been able to feed itself and move independently almost from birth, researchers said. The soft enamel and configuration of its teeth suggest that it was a meat-eater, with a diet of aquatic animals.
The discovery challenges some conventional assumptions about the life history of primitive whales. “The geological age of Tutcetus is a bit older than other closely related fossil whales, which hints that some evolutionary changes in whale anatomy happened a bit earlier than we suspected,” said Nicholas Pyenson, curator of fossil marine mammals at the Smithsonian’s National Museum of Natural History, who was not involved in the work. “The fossil pushes back the timing of how the earliest whales changed from foot- to tail-propelled movement in the water.”
Whales have an unexpected past. Genetically they are closely related to hoofed mammals, called ungulates, and within that group they are most similar to the artiodactyls, such as camels, pigs, giraffes and hippos, all of which have an even number of toes. One of the best-known early forebears of whales was a 50-million-year-old quadruped called Pakicetus that waded in the estuaries of southern Asia, ate meat and, by some accounts, might have resembled a large house cat with hoof-like claws.
Scientists were able to link Pakicetus to the evolutionary lineage of whales because it had an ear bone with a feature unique to those modern-day giants of the deep. “Importantly, its ankle bones look like those of artiodactyls and helped to support the link of whales to artiodactyls that had previously been suggested by DNA,” said Erik Seiffert, an anatomist at the University of Southern California who collaborated on the paper.
The artiodactyls begot the semiaquatic ambulocetus, a so-called walking whale that looked like a crocodile, swam like an otter and waddled on land like a sea lion. “Ambulocetus actually still had fairly well-developed hind limbs, so it wouldn’t have had a hard time getting around on land,” Dr. Seiffert said. Ambulocetus, in turn, begot protocetid, a more streamlined halfway creature that fed in the sea, but may have returned to land to rest. Over evolutionary time, its hind limbs became smaller, and it maneuvered entirely with its tail.
Eventually, these proto-cetaceans gave rise to archaeocet, a fully aquatic basilosaurid. Aided by flippers and paddle-like tails, basilosaurids dispersed through the oceans worldwide. The one that turned up on that Alabama plantation in 1842 may even have crossed the Atlantic.
Mohammed Antar, a paleontologist at Mansoura University who dug up the Tutcetus fossil and was first author of the new paper, said climate and location may have made the Fayum Depression inviting to basilosaurids. “Modern whales migrate to warmer, shallow waters for breeding and reproduction, mirroring the conditions found in Egypt 41 million years ago,” he said.
The setting seems to have provided relatively safe harbor for female whales to give birth in shallow waters. “As far as we can tell from the abundant fossils of tree-living primates found there, the area lining the northern edge of what is now the Sahara was effectively a tropical forest during the middle Eocene,” Dr. Seiffert said. The protected coasts of northern Africa, he added, “might have allowed whale calves time to mature and reach a level of navigational and feeding proficiency before heading out into open water, then very deep water.”
In August, shortly before the diminutive Tutcetus was unveiled in Egypt, paleontologists working in Peru reported the discovery of an extinct whale that may have been the heaviest animal ever. Perucetus colossus swam the oceans 38 million years ago and is estimated to have weighed as much as 200 tons, a figure comparable to the blue whale, the current record-holder.
Perucetus and Tutcetus were alive just a few million years before primitive whales began their evolutionary split into the two cetacean suborders of today: the toothed whales, dolphins and porpoises known as odontoceti, and the baleen-bearing mysticeti, including blue whales and humpbacks.
“The mysticetes tend to be much larger than the odontocetes,” said Jonathan Geisler, an anatomist at the New York Institute of Technology. “And this difference is related to their different feeding strategies.” Toothed whales hunt individual prey such as fish and squid, while baleen whales filter-feed to gather krill, copepods and tiny schooling fish.
“Understanding the size of the ancestor of all modern whales helps us understand how these feeding behaviors and distinct body size differences evolved,” Dr. Geisler said. “Tutcetus is one data point in the effort, but it supports the hypothesis that the common ancestor of all living cetaceans was fairly small.”
Dr. Sallam said that similar to the way Melville, reflecting on the Basilosaurus skeleton found in 1842, imagines a time when “the whole world was the whale’s,” the discovery underscores the transient nature of existence and provides a tangible connection to a prehistoric past. “The significance of the find, like the fossils described in ‘Moby Dick,’ extends beyond the realm of paleontology,” he said. “It highlights the enduring fascination with Earth’s ancient history.”
Video: Space Capsule Brings NASA’s First Asteroid Samples to Earth
new video loaded: Space Capsule Brings NASA’s First Asteroid Samples to Earth
Space Capsule Brings NASA’s First Asteroid Samples to Earth
NASA collected a capsule, which contained materials from the asteroid Bennu, after it landed in the Utah desert, concluding a seven-year mission.
“We have confirmed parachute deployment.” “Wow, and after an exhilarating streak across Earth’s atmosphere, we have parachute deployment. You can see just a sigh of relief from the team. I can hear some applause here. You see the reaction there just moments ago as they got that sample back on the ground. The rest of the team members approaching that S.R.C. that has been successfully bagged and prepared to be loaded into the helicopter’s long line. And we have clearance to depart the recovery site. This is a key moment of those recovery operations. We’re already getting that S.R.C out of the landing zone and on its way to the Dugway clean room. In just a few moments, the SR.C. will be back on the ground, its second touchdown of the day, a much calmer one than we had earlier this morning. The doors are now open. We are entering into the clean room and that S.R.C. is about to be moved off onto our clean room fixture. It’s hard to fathom that just a couple of years ago, this sample return capsule that you see here was over 200 million miles away from us on the other side of the solar system.”
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